Trial intelligence / Profile preview

ALVOPAD-X: Interchangeability of AVT02 and Humira in Psoriasis

NCT04453137Phase 3

Key facts

Status: Completed
Start: Jun 2020
Primary completion: May 2021
Countries: 5
Sponsor: Alvotech
Modality: Monoclonal Antibodies

Drugs: AVT02
Conditions: plaque psoriasis

Overview

Phase 3, randomised, double-blind trial of AVT02 in plaque psoriasis (2 arms), sponsored by Alvotech. Primary endpoints: Area under the concentration-time curve over the dosing interval and Maximum concentration over the dosing interval. Started Jun 2020; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Switching Group
Received Humira in Lead-In, then switched AVT02 (4w) -> Humira (4w) -> AVT02 (8w) during Switching Module.
Continuing Group
Received Humira in Lead-In and continued Humira during Switching Module.

Who it enrols

Patients with moderate-to-severe chronic plaque psoriasis (BSA >= 10%, PASI >= 12, sPGA >= 3) who are candidates for systemic therapy and naive to adalimumab.

Endpoints

Primary

Area under the concentration-time curve over the dosing intervalWeek 26 to Week 28
Maximum concentration over the dosing intervalWeek 26 to Week 28

Secondary

Psoriasis Area and Severity IndexWeek 1 to Week 28

Results

Primary endpoints met

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